Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT05089851
Eligibility Criteria:
Inclusion Criteria:
1. Female subjects must be between 35-60 years of age.
2. Female subjects of childbearing potential must be willing to use a form of birth control during the study.
3. Subjects with Fitzpatrick I-VI photo skin type.
4. Subjects must have moderate to severe crow's feet facial wrinkles (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
5. Subjects must have moderate to severe crow's feet fine lines (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
6. Subjects may have mild to moderate photo-aging (score 3-6 on 0-9 scale) secondary to physiologic aging, hormonal influences, and environmental stressors.
7. Subjects must have no skin disease in the facial area being evaluated.
8. Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
9. Subjects must be willing to provide verbal understanding and written informed consent
Exclusion Criteria:
1. Female subjects who are pregnant, breast feeding, or planning a pregnancy.
2. Subjects with severe overall photo damage (score 7-9 on 0-9 scale) as determined by the Investigator.
3. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products or to the botulinum toxin.
4. Subjects who are unwilling or unable to comply with the requirements of the protocol.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT05089851
Study Brief:
Protocol Section:
NCT05089851